Device product
CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-3007-2018
Product summary
- Event
- Event 80807
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1719 units
- Official record key
device-enforcement:Z-3007-2018
Official wording
Reason: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Code information: Lot Numbers: Y18586, Y24472, UDI: 4015630972234
Distribution pattern: worldwide
Derived failure modes
-
Unknown
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.